• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

What does FDA require drug manufacturers to do to prevent contaminated drugs? If contamination occurs, how must they correct the problem?

To prevent contamination and ensure product quality, FDA requires companies to follow Current Good Manufacturing Practice regulations (CGMPs) for manufacturing drugs.  If contamination is discovered during production of a drug, manufacturers must not distribute the product and must correct the problem, using a “corrective action plan.”  Sometimes, however, contamination is discovered after distribution.  If this occurs, FDA expects manufacturers to recall affected batches, investigate, and take measures to prevent it from happening again.  When a batch is recalled, FDA:

  • Asks the company to stop shipping and to recall product that has already been shipped;
  • May take samples for analysis to find the contamination's source and may also use the company's production records to find out the extent of how much product could be involved;
  • Conducts a health hazard evaluation (HHE) to determine how the public might be affected;
  • Works with the company to issue public notices and recall alerts;
  • Oversees the company’s corrective action plan, which can include re-inspection by FDA and contacting distributors and retailers to ensure product is recalled.

FDA cannot order a firm to recall a drug. If a company will not cooperate with a recall or investigation, FDA can take regulatory action.  If FDA finds contamination because the manufacturer did not follow CGMPs, FDA may take enforcement action that can include issuing warning letters, seizing product, obtaining court orders to prevent further manufacturing, or even criminal fines and jail time.  FDA may also request a state regulatory body to take action. 

Basics Question toggle Show all related FDA Basics Questions


How helpful was this information?


Not HelpfulArrow pointing to the rightVery Helpful

Please limit your feedback to 1000 characters.

Please limit your feedback to 1000 characters.

If you would like to ask a specific question, please visit our "Contact Us" page for more information about how to contact FDA.

Please note that any information you submit may become public or subject to release under the Freedom of Information Act (FOIA). For more information, read about our privacy policies and the FOIA.